A PROSPECTIVE STUDY EVALUATING THE EFFECTIVENESS OF EPIDURAL VOLUME EXTENSION WITH NORMAL SALINE IN COMBINED SPINAL EPIDURAL ANAESTHESIA FOR LOWER LIMB
ORTHOPAEDIC SURGERIES USING LOW DOSE INTRATHECAL HYPERBARIC BUPIVACAINE
Dissertation submitted in partial fulfilment of the requirements for award of the degree M.D. (Anaesthesiology) Branch X
GOVT. KILPAUK MEDICAL COLLEGE CHENNAI-10
THE TAMIL NADU DR. M.G.R. MEDICAL UNIVERSITY CHENNAI, TAMILNADU
APRIL 2017
CERTIFICATE
This is to certify that this dissertation entitled “A PROSPECTIVE STUDY EVALUATING THE EFFECTIVENESS OF EPIDURAL VOLUME EXTENSION WITH NORMAL SALINE IN COMBINED SPINAL EPIDURAL ANAESTHESIA FOR LOWER LIMB ORTHOPAEDIC SURGERIES USING LOW DOSE INTRATHECAL HYPERBARIC BUPIVACAINE” submitted by Dr. ASHWINI.S in partial fulfilment for the award of the degree Doctor of Medicine in Anaesthesiology by The Tamilnadu Dr. M.G.R. Medical University, Chennai is a bonafide work done by her at GOVERNMENT KILPAUK MEDICAL COLLEGE, CHENNAI during the academic year 2014-2017.
Prof.Dr.R.Narayanababu,M.D.,DCH., Prof.Dr.T.Murugan,M.D.,D.A., Dean Professor & HOD
Govt. Kilpauk Medical College Department of Anaesthesiology Chennai-10 Govt. Kilpauk Medical College
Chennai- 10
DECLARATION
I, Dr. ASHWINI.S, solemnly declare that this dissertation, entitled “A PROSPECTIVE STUDY EVALUATING THE EFFECTIVENESS OF EPIDURAL VOLUME EXTENSION WITH NORMAL SALINE IN COMBINED SPINAL EPIDURAL ANAESTHESIA FOR LOWER LIMB ORTHOPAEDIC SURGERIES USING LOW DOSE INTRATHECAL HYPERBARIC BUPIVACAINE”, has been prepared by me, under the expert guidance and supervision of Prof.Dr.T.Murugan,M.D.,D.A, Professor and HOD, Department of Anaesthesiology, Government Kilpauk Medical College and Hospital, Chennai and submitted in partial fulfilment of the regulations for the award of the degree M.D.(Anaesthesiology) by The Tamil Nadu Dr.
M.G.R. Medical University and the examination to be held in April 2017.
This study was conducted at Government Kilpauk Medical College Hospital and Government Royapettah Hospital, Chennai. I have not submitted this dissertation previously to any university for the award of any degree or diploma.
Place: Chennai Date:
(DR.ASHWINI.S)
DECLARATION BY THE GUIDE
This is to certify that this dissertation entitled “A PROSPECTIVE STUDY EVALUATING THE EFFECTIVENESS OF EPIDURAL VOLUME EXTENSION WITH NORMAL SALINE IN COMBINED SPINAL EPIDURAL ANAESTHESIA FOR LOWER LIMB ORTHOPAEDIC SURGERIES USING LOW DOSE INTRATHECAL HYPERBARIC BUPIVACAINE” submitted by Dr. ASHWINI.S in partial fulfilment for the award of the degree Doctor of Medicine in Anaesthesiology by The Tamilnadu Dr.M.G.R. Medical University, Chennai is a bonafide work done by her at GOVERNMENT KILPAUK MEDICAL COLLEGE, CHENNAI during the academic year 2014-2017, under my guidance and supervision.
Prof.Dr. Valli Sathyamoorthy,M.D.,D.A., Professor
Department of Anaesthesiology Govt. Kilpauk Medical College Chennai - 10
ACKNOWLEDGEMENT
I wish to express my sincere thanks to Dr.R.Narayana babu,M.D., DCH., Dean, Government Kilpauk Medical College, Chennai for having kindly permitted me to utilize the facilities of the college for the conduct of the study.
I am extremely grateful to the Professor and Head of the Department of Anesthesiology, Govt. Kilpauk Medical College, Prof. Dr. T.Murugan, M.D.,D.A., for his motivation, valuable suggestions, inspiration, meticulous guidance, expert advice and constant encouragement in preparing this dissertation and for providing all necessary arrangement for conducting the study.
I am grateful and indebted to Prof.Dr.R.Kundhavi devi, M.D.,D.A., Professor, Department of Anaesthesiology, Government Kilpauk Medical College, Chennai for her concern.
I also express my sincere gratitude to all other Professors of Anaesthesiology, KMC, Prof. Dr.Valli Sathyamoorthy, MD., DA., Prof. Dr.
A.Chandrasekaran , M.D., Prof.Dr.S.Krishnakumar,M.D., for their constant motivation, encouragement and valuable suggestions.
I thank all the Assistant Professors and tutors of Anaesthesiology KMCH and GRH for their keen interest and support without which this study would not have been possible.
I am thankful to the Institutional Ethics Committee for their guidance and approval of the study.
I also thank my colleague Postgraduates for supporting me throughout the study.
I thank the Department of Orthopaedics, KMCH and GRH and their faculty members for their kind cooperation and permitting me to use the hospital facilities for the study.
I also thank the theatre personnel for their co-operation and assistance.
I wish to thank all the patients whose willingness and patience made this study possible.
I finally thank God Almighty for His blessings in successfully completing the study.
TABLE OF CONTENTS
S.NO TITLE PAGE NO
1 INTRODUCTION 1
2
COMBINED SPINAL EPIDURAL
ANALGESIA 3
3
RATIONALE BEHIND EPIDURAL
VOLUME EXTENSION 24
4
ORTHOPEDICS AND REGIONAL
ANAESTHESIA 25
5
PHARMACOLOGY OF BUPIVACAINE
AND FENTANYL 27
6 REVIEW OF LITERATURE 37
7 AIM OF THE STUDY 44
8 MATERIALS AND METHODS 45
9 OBSERVATION AND RESULTS 52
10 DISCUSSION 71
11 SUMMARY AND CONCLUSION 77
12 BIBILIOGRAPHY 79
13 ANNEXURES 87
1
INTRODUCTION
Combined spinal epidural anaesthesia technique for providing pain relief for orthopaedic procedures has gained popularity. This technique is done as a one-time procedure where first the epidural space is located and intrathecal administration of either a combination of local anaesthetic and opioid or each component separately is done, followed by catheter insertion in the epidural space. It combines the advantages of rapid onset and the reliability of blockade obtained spinally along with the flexibility given by epidural catheter avoiding the disadvantages of either technique used alone.
The combined spinal epidural anaesthesia technique (CSE), first reported in caesarean section in 1984, has recently gained popularity. Spinal anaesthesia has a very rapid onset of action providing a dense neural blockade of finite duration. Epidural anaesthesia is more titratable producing less hemodynamic swings and can also provide postoperative analgesia. Combined spinal epidural anaesthesia technique provides the advantages of both subarachnoid and extradural anaesthesia thus decreasing their failure rates when used alone.
Even skilled anaesthesiologists are unsuccessful in performing subarachnoid or epidural anaesthesia solely in 2-5 % of the cases. The failure rate is reduced to 0.16% if both the procedures are combined. The epidural volume extension adds colour to combined spinal epidural anaesthesia technique where the onset and the level of blockade obtained spinally is
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enhanced by administering saline or local anaesthetic via the epidural catheter.
The ideology behind this is the volume effect accomplished by injecting saline epidurally which would result in intrathecal compression and cephalad migration of spinal local anaesthetic.
This study was aimed to identify the effectiveness of block profile provided by extending the epidural volume with normal saline for lower limb orthopaedic surgeries using a low dose intrathecal hyperbaric bupivacaine without causing hemodynamic changes. The majority of lower extremity orthopaedic surgery patients are old age and have multiple coexisting medical problems. Ensuring hemodynamic stability in these patients requires selection of appropriate techniques of regional anaesthesia, focussing on maintaining a safe and desirable level of blockade and limiting extensive sympathectomy.
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COMBINED SPINAL EPIDURAL ANALGESIA ANATOMY
The epidural space is the most experimented cavity in human beings. It was first described by Corning1 in 1901. The anatomical space between the duramater and the vertebral canal is called the epidural space. It was thought to be a real space while in reality it is merely a potential space.
24 individual vertebrae forms the vertebral column constituting 7 cervical, 12 thoracic, 5 lumbar while the fused vertebrae includes 5 sacral and 3 to 5 coccygeal bones remaining rudimentary. The epidural and the subarachnoid spaces are housed and protected by these vertebrae. The fusion of the membranes of the medulla spinalis and the duramater overlying the periosteum at the foramen magnum forms the upper boundary of the epidural space, whereas the sacrococcygeal membrane forms the lower limit. The bodies of vertebrae along with intervertebral discs and posterior longitudinal ligament binds the epidural space anteriorly while laterally it is encircled by the pedicles and intervertebral foramina.
EMBRYOLOGY
At the gestational age of 13 weeks, the connective tissues plug the epidural space and the posterior longitudinal ligament and the duramater are tethered. Three stages differentiate the evolvement of the epidural space inside the connective tissue at the 13th week subsequently. These are namely the
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primary epidural space formed in embryos measuring 16-31 mm crown rump length , reduction in the volume of the primary epidural space occurs when embryos measure about 35-55 mm crown rump length and formation of the secondary epidural space occurs at the embryological growth phase of 60-70mm crown rump length.
The attachment of the vertebral body to the posterior longitudinal ligament lateral to the midline and to the dorsal margin of intervertebral disc occurs at the 15th week of embryonic life. At week 21, the binding between the duramater and posterior longitudinal ligament is ligament like at the vertebrae.
At week 32, the superficial layer of posterior longitudinal ligament and the duramater are adherent. Groups of adipocytes begin to develop at the 39th week.
The upper thoracic regions of the spinal cord has the most roomy epidural space. The epidural space at the level of C7-T1 in adult measures 0.4 mm posteriorly, in the upper thoracic region it measures about 7.5 mm, calibration of 4.1mm at T11-T12 and in the lumbar region it is about 4-7mm. This space is much greater in volume when compared to the corresponding subarachnoid space at the same level. It takes about 0.3 ml of a local anaesthetic to block a spinal segment in the subarachnoid space while about 1.5-2 ml of local anaesthetic is required to produce an epidural block.
The cervical, thoracic, lumbar and sacral spaces form the divisions of the epidural space. They are defined according to their margins. The membranes of
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medulla spinalis and dura mater lining the periosteum fuses from the foramen magnum till the lower border of vertebrae prominens to form the cervical epidural space. While from the lower boundary of C7 to the upper boundary of L1 constitutes the thoracic epidural space. The extension of the lumbar epidural space is from the lower border of L1 vertebra till the upper border of S1 vertebra. The upper margin of S1 to sacrococcygeal membrane demarks the sacral epidural space.
The inbuilt negative pressure within the epidural space limits its demarcation. There are two theories explaining this negative pressure. The Cone Theory states that the needle introduced into the epidural space depresses the dura, consequently creating a larger epidural space. It is thus considered an artefact caused by the indentation of the dura by the advancing needle. Telford and Holloway2 demonstrated that epidural space pressures were always positive and negative pressures were only recorded when there is tenting of the dura with a relatively blunt needle. The Transmission Theory considers that the vacuum in the epidural space is caused by the transmission of the intrapleural negative pressure via the intervertebral foramina to the peridural space. This negative pressure is greatest at points of firm attachment and in the thoracic region. It is less in the lumbar region and least or absent in the sacral area. Gil et al.3 ,2008 demonstrated that specifically in the thoracic epidural space, particularly in the sitting posture, there is development of more negative
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pressure than in the lateral recumbent position. This therefore clearly shows that when the hanging drop technique is used to identify the epidural space, sitting position defines the epidural space more distinctly.
The constituents of the epidural space
Semi-liquid fat, epidural arteries, loose areolar connective tissue, lymphatic channels, the nerve roots of the spinal cord, and a vast venous plexus are contained in the epidural space. Hogan4, 1998 proved that the contents of the epidural space are segregated by distinct zones where the vertebral canal comes in contact with the duramater and arranged in a circumferential series of compartments discontinuously.
Semi-liquid Fat
There has been numerous studies about the fat distribution in the epidural space. A study carried out by Reina et al5., 2006 proved that there is a predictable pattern of distribution of epidural fat abundantly within the spinal canal. Adipocytes are also numerous in the duramater, sleeving the spinal nerve roots. There is no embedment of fat cells within the laminas of the dural sac which form the dura mater. The pulsatile movements of the dural sac is buffered by these adipocytes in the extradural space which also serves to protect the neural elements. Thus this creation of a lipophilic reservoir facilitates smooth movements during flexion and extension of the spine allowing the dural sac to slide over the periosteum of the vertebrae. Reina et al5., 2006 showed the
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continuous metameric pattern of arrangement of the epidural fat in human adults. The storehouse of fat in the dural sleeves could act as reservoir of drugs thus leads to greater effect on nerve roots compared to the drugs stored in epidural fat. This is due to the proportionately larger concentration of fat near the nerve roots, and their closer proximity.
Reina et al.5, 2009 also highlighted that the pathologies altering the distribution or fat content changes the absorption or distribution of drugs administered in the epidural space.
Anatomy of Epidural Space
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Applied Anatomy and Clinical Importance of the Epidural Space
The distribution of adipocytes is predominantly on the dorsal region of the space. It is connected via a vascular pedicle to the middle of the ligamentum flavum and arranged in triangular capsular shapes. This peculiarity of the adipocyte arrangement contributes to the resistance during epidural catheter insertion and for the pharmacokinetics of local anaesthetics and drugs injected into the space to act on the dorsal spinal nerve roots.
Lymphatic System
The lymphatic system contained within the epidural space act as scavengers by removing the foreign particles including microbes from the epidural and subarachnoid spaces. The dural roots mainly harbour the lymphatics.
The Valveless Vertebral venous plexus
Domisse6, 1975; Parkin and Harrison7, 1985; Brockstein et al8., 1994 thoroughly studied the internal vertebral venous plexus and found them to be anchored within the epidural space. Mehl9, 1986 claimed that this plexus of veins caused tapping of blood in the epidural needle. There are four longitudinal interconnecting vessels, two anterior and two posterior which contribute to the internal vertebral venous system. Williams et al10., 1989 on the contrary showed that the external vertebral plexus is made up of anterior and posterior plexus of
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veins lying peripheral to the vertebrae. Being located anterior to the vertebral bodies the external vertebral venous system is related to the laminae, spinous processes, transverse processes and articular processes of the vertebrae respectively.
The segmental veins of the neck, the intercostal, azygos and lumbar veins form the communicating channels of this system. Batson’s vertebral venous plexus is formed by the network of periosteal veins of the vertebral column, along with the internal and external vertebral plexuses. (Domisse6, 1975). Being predominantly situated in the anterior and lateral portion of the epidural space, these veins unite with the azygous venous system finally. During conditions like ascites and pregnancy, increase in intrathoracic or intra-abdominal pressures is directly transmitted to this system as the entire system is valveless, leading to major congestion and enlargement of vessels within the spinal canal. A sparse quantity of fat circumference the epidural venous plexus.
A rich valveless venous plexus fills the anterior epidural space. The plexus makes important communications with the cerebral venous system namely, the sigmoid sinus, basilar veins, vertebral vein, occipital veins, and the azygous vein. The transmission of abdominal and thoracic cavity pressures to the epidural space is because of the linkage with the abdominal and thoracic venous system via the intervertebral foramina. The sacral venous plexus is formed by the connection of vertebral venous plexus with the iliac veins. There
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is an increased risk of bleeding while securing the epidural needle or catheter when there is distension of the venous plexus during advanced stages of pregnancy, obstruction of inferior vena cava or abdominal cavity malignancies.
Arteries of the epidural space
The branches of the ilio-lumbar arteries forms the vascular supply to the lumbar epidural region. Advancement of the epidural needle does not injure these arteries as they are found laterally.
Epidural Space and its contents
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Identifying the extradural space
Identifying the epidural space is a demanding technique and as anaesthesiologists it is of crucial importance. The first demonstration of this space was made by Dogliotti11, 1933 about 83 years back. The functionality of the epidural analgesia depends upon the accuracy of detection of the epidural space. As the epidural needle is inserted in the midline, it pierces the skin, the subcutaneous tissue, the supraspinous, interspinous ligament and has to traverse the ligamentum flavum to reach the space. The depth of the epidural space is defined as the distance from overlying skin to the tip of the needle just penetrating into the epidural space (Lai et al.12, 2005). In obese patients the depth is difficult to identify.
To improve the probability of success rate in identification of the peridural space, Ravi et al13., 2011 found out a correlation between the body mass index(BMI) and the depth of the epidural space This study showed that the depth of the epidural space increased significantly as the BMI increased. Based on linear regression analysis, the equation for depth of epidural space is
Depth (mm) = a + b (BMI).
Where a = 17.7966 and b = 0.9777.
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Identification of the epidural space
Negative pressure contributes to the most traditional method of spotting the epidural space. In order to minimize the associated complications, any technique identifying the epidural space should be simple, safe and reliable.
Loss of resistance (LOR) is one of the most reliable technique in identifying the extradural space. In this method a glass or plastic syringe is filled with either air or saline or local anaesthetic and advanced from the skin by applying a continuous or intermittent pressure on the piston. The point where it becomes possible to inject through the syringe marks the loss of resistance. As the injection through the ligamentum flavum is not possible, this technique always works better. The syringe may contain air or saline. Since air has a greater compressibility than saline or local anaesthetic, the specifications of the technique are different whereas it carries the same principles.
The identification of the epidural space with LOR to lidocaine or air plus lidocaine has minimal chance of puncturing the dura as compared to air alone and technique wise also it is potentially difficult. Evron et al14., 2004 has stated that sequential use of air and lidocaine has no benefits over lidocaine alone . The complications associated with this technique has been studied. Nay et al15., 1993 proved that paraplegia could result from LOR to air, the development of pneumocephalus was highlighted by Nafiu & Bullough16, 2007. Okutomi &
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Hoka17, 1998 insisted the association between LOR to saline and the dilution of the injected local anaesthetic.
Hanging Drop Sign: A small drop of sterile distilled water is placed on the hub of the needle after it is introduced to the level of resistance indicating the beginning of the ligamentum flavum. When the needle is advanced through the yellow fibrous tissue, this drop will be sucked into the epidural space. This is called the “sign of the drop”.
Capillary Tube Method: Odom developed an improved method for detecting the epidural space where he devised a small capillary tube filled with sterile saline in which one or two bubbles of air were placed. These acted as a meniscus. As soon as the needle entered the epidural space, the saline was sucked in and the air bubbles could be seen advancing into the space.
Michel & Lawes18, 1991 devised a new technique called modified drip method to identify the epidural space. In this trial, an infusion of saline was filled in the tubing and attached to the hub of the epidural needle and the distal 40 cm was left full of air. In a majority of cases, precise identification of the extradural space was accomplished in a petty time. In contrast to the manual loss of resistance technique and hanging drop method, this study showed a clear edge.
Lin et al19., 2002 observed a novel approach called as “membrane in syringe” with two distinct benefits. A syringe is divided into two halves by
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keeping a plastic membrane in the middle. The distal nozzle end of the plastic syringe is filled with saline. The other hollow cylindrical portion of the syringe is closed with the plunger. The air compartment is the space enclosed between the rubber plunger and the plastic membrane. First and foremost advantage of this technique is that air entrance is prohibited without hampering the feel of compressibility. Wrinkling of the plastic membrane and injection of saline indicates the entrance into the epidural space is the second benefit of this technique.
The Macintosh epidural balloon serves as a simple method in identifying the extradural space. A small balloon is filled with 2 to 3 ml of air and lodged on to a glass adapter attached to the epidural needle when it reaches the ligamentum flavum. The collapse of the balloon signifies the epidural space penetrance. Fyneface-Ogan & Mato20, 2008 weighed the identification characteristics of both epidural balloon and loss of resistance technique and ascertained that the space could be more swiftly detected at the first attempt by the epidural balloon although the cost factor plays a role.
Samada et al21., 2011 invented an optimal pressure producing loss of resistance device called the Epidrum for localising the epidural space. The operation of the device is at a high pressure set to be liberated into the extradural space, taking care not to cause premature leakage into the patient’s tissues. An extremely thin diaphragm situated at the top of the Epidrum acts as
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the meniscus of a manometer to create an optimal pressure. This facilitates the operator to identify the position of the needle tip with help of the diaphragm's signal. Epidrum has the following advantages
• Shorter learning curve as the procedure is comparatively simple. When the trainee is performing the procedure the trainer can monitor the diaphragm signal.
• It is an effective, trustworthy and harmless procedure.
• Post dural puncture headache and the risk of epidural haematoma formation could be drastically prevented by using a smaller needle
• A visual endpoint is offered.
• False positive errors could be minimized by using an optimized, low and constant pressure
• Dural tap can be easily seen by the draining cerebrospinal fluid
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Loss of Resistance Syringe and its Technique
HISTORY
• Soresi was the first person to perform Combined Spinal Epidural technique in 1937.
• Cerelaru used separate spaces for each component in 1979.
• Brownridge in 1981 advised the use of CSE in caesarean section.
• Carrie in 1984 described needle through needle technique.
• Dr. Morgan in 1993 introduced CSEA (combined spinal epidural analgesia) for labour – walking epidurals.
EQUIPMENTS REQUIRED:
EPIDURAL NEEDLE:
The Epidural needle most commonly used is 16G or 18G Tuohy needle with bent tip with 8 cm/10 cm long shaft. A radical improvement suggested by
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Huber resulted in bending the point and placing the bore opening on the side of the point. This is called Tuohy-Huber point needle with a blunt leading edge and a lateral opening at the tip. The Epidural catheter is 16G or 18G with single hole at the end or closed end with side holes at multiple levels. A 0.2 micrometer filter at proximal end is to prevent contamination by bacteria and injection of particulate matter through the catheter. Other types of epidural needles are Crawford Point Needle and Hustead Needle.
SPINAL NEEDLE:
Quincke Babcock’s needle 23G - 27G is most commonly used standard spinal needle. It has a small hub and a sharp point with a medium length cutting bevel. A stylet is fitted matching the bevelled tip to the cannula point. The hub is designed with a Luer-Lock connector. Other types are fine gauge needles (24G -27G) with a pencil point tip (Sprotte or Whitacre). The combined spinal epidural kit consists of 8cm Tuohy needle with 120 mm spinal needle or 10 cm Tuohy needle with 150 mm spinal needle. Optimum protrusion of spinal needle in the kit is 1.7 cm.
CSE TECHNIQUES:
• SINGLE PASS :
It was first described by Soresi in 1931. In this technique needle introduced into the epidural space injects some quantity of local
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anaesthetic and then advanced further into the subarachnoid cavity where subsequent dose of local anaesthetic is deposited. It is not used nowadays and there is no longevity of the block.
• NEEDLE THROUGH NEEDLE:
16 G or 18 G epidural needle is used to identify the epidural space.
Spinal needle of size 24G to 27G is then introduced via the epidural needle, till dural piercement is felt. Spinal needle stylet is then removed.
Cerebrospinal fluid needs to be visualized in the hub of the spinal needle.
Injection of local anaesthetic agent is done. Spinal needle is taken out and about 3.5 cm of the epidural catheter is placed inside. Epidural catheter is secured with sterile tapes and used to prolong pain relief once the spinal anaesthesia wears off.
• NEEDLE THROUGH NEEDLE ( BACKEYE+) :
Epidural needles, with back-eye on the curve, specially designed for allowing spinal needle introduction in a straight line, tip coming out through the back-eye, entering the subarachnoid space. The epidural catheter then travels along the curved part of the epidural needle and the tip is positioned cephalad.
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Needle through Needle Technique
• LOCKING NEEDLE THROUGH NEEDLE:
It has locking device to stabilize the spinal needle with the epidural needle, after identifying the epidural space, which provides stability to the spinal needle.
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• SEPARATE NEEDLES THROUGH SEPARATE INTERSPACES:
Epidural catheter and spinal needle are introduced separately at two different intervertebral spaces. Possibility of catheter injury by the spinal needle tip cannot be ruled out.
• SEPARATE NEEDLES THROUGH SAME INTERSPACES :
Epidural catheter is placed first followed by spinal needle insertion and then the subarachnoid drug administration. Provides good patient satisfaction.
• COMBINED NEEDLE :
This avoids the friction, supposed to occur while using needle through needle technique and separates the epidural and spinal components.
• DUAL CATHETER TECHNIQUE :
Spinal and epidural catheterization can be done separately. They have the possibility of catheter entanglement, cauda equina syndrome and accidental subarachnoid injection of high volume of drugs, mistaking spinal for epidural catheter that might result in total spinal anaesthesia.
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SPINAL ANAESTHESIA ALONE ADVANTAGES:
• Rapid onset
• High reliability than epidural
• Dose requirement reduced, prevents toxicity
• End point of needle placement is definite.
DISADVANTAGES:
• No options to extend the blockade.
• As dura is deliberately breached, the risk of postdural puncture headache is high.
EPIDURAL ANAESTHESIA ALONE ADVANTAGES:
• Used widely
• Familiarity of the technique
• Epidural catheter allows top up doses to produce alteration or prolongation of the blockade
• Hypotension occurs slowly when compared to subarachanoid blockade.
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• Postdural puncture headache is uncommon, unless accidental dural puncture occurs.
DISADVANTAGES:
• Slow onset
• Sometimes asymmetrical or patchy
• Huge volume of local anaesthetic agents needed
• Certain spinal nerve roots could not be blocked.
COMBINED SPINAL EPIDURAL ANAESTHESIA CAN THUS PRODUCE…
• Rapid induction of anaesthesia
• The quality of pain relief is better
• Low dose of local anaesthesia required
• Epidural catheter can prolong and optimize spinal block COMPLICATIONS OF CSE TECHNIQUE:
• Technically difficult
• Extensive blockade This may be due to
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• Bolus of epidural local anaesthetic agent may act on the spinal nerves.
• The epidural drugs may cross the dural membrane
• Accidental migration of catheter tip to the intrathecal cavity.
-Epidural bolus of anesthetic agent can extend the intrathecally administered drug, only while the subarachanoid blockade is developing (13 minutes)
• Postdural puncture headache
• Meningitis
• Neurological sequalae is rare.
COMBINED SPINAL EPIDURAL KIT
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RATIONALE BEHIND EPIDURAL VOLUME EXTENSION
Epidural volume extension (EVE) is an alteration of the CSE technique where normal saline injected into the peridural space after subarachnoid injection of hyperbaric bupivacaine. This is aimed at rapidly increasing the sensory level obtained spinally by causing thecal compression to ascend the intrathecal drug.
EVE is a unique technique for regional anaesthesia which offers reliability and rapidity of spinal anaesthesia along with the flexibility of epidural anaesthesia. Desired degree of surgical anaesthesia is achieved with a small dose of local anaesthetic which prevents adverse hemodynamic effects seen with the conventional doses. It avoids the disadvantages of general anaesthesia in patients with high cardiac risk by avoiding the cardiodepressant drugs.
We could titrate the level of anaesthesia, vary the intensity of block, extend the duration of anaesthesia and also deliver postoperative analgesia.
Provides early ambulation and is also cost effective. EVE is a novel technique which is increasingly being used nowadays for orthopaedic, gynaecological and urological procedures thus commanding a unique place in the anaesthesiologist’s armamentarium.
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ORTHOPAEDICS AND REGIONAL ANAESTHESIA
A maximum proportion of the patients coming for orthopaedic surgeries are middle aged and elderly. As the age advances, there is a constant deterioration in the functional reserve thus not sparing any organ system.
Accordingly, the response of the elderly people to surgery and anaesthesia are varied.
The response of the geriatric patients to stress and illness is unpredictable due to the coexistence of numerous major medical conditions. These patients present commonly with alterations in the respiratory mechanics with impaired efficiency of gas exchange. Structural alterations in the upper and lower airways occur. Cardiovascular and autonomic aging leads to an unstable blood pressure and hypokinesia with lower ejection fraction. Diabetes mellitus, coronary artery disease, ischemic cardiomyopathy, moderate left ventricular dysfunction, severe right ventricular dysfunction, severe pulmonary artery hypertension are commonly presented to the orthopaedic department following trauma.
The options that could be pondered broadly include spinal or general anaesthesia. EVE has emerged as a resolving technique for all undesirable elderly changes. It has significant dose sparing effect providing the required level of anaesthesia and analgesia without compromising the hemodynamic profile of the patient. It has offered the advantage of regional and general anaesthesia at the same time avoiding the undesirable side effects of both the
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techniques. It also provides a backup in case spinal anaesthesia fails. It offers a clear edge over general anaesthesia eliminating airway manipulation and the accompanying stress response which would adversely affect the patient’s cardiovascular status. It alleviates the negative inotropic effects of anaesthetic agents and the adverse effects on the venous return due to positive pressure ventilation.
The mild vasodilatation achieved by subarachnoid block by EVE’s technique is found to be advantageous in patients with isolated left ventricular dysfunction. Thus EVE in CSE technique is highly efficacious well-tailored approach with careful fluid administration under the guidance of intensive monitoring helps to achieve our anaesthetic aim.
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PHARMACOLOGY OF BUPIVACAINE
Bupivacaine is an amide local anaesthetic agent. It belongs to the homologous series of n-alkyl substituted pipecholyl xylidine group. It was first synthesized by Ekenstam in 1957 and was used clinically in 1963. It is produced for clinical use as a racemic mixture containing both ‘S’ and ‘R’
forms in equal proportion. It is supplied as a hydrochloride salt CHEMICAL STRUCTURE:
1-butyl-n-(2, 6-dimethyl phenyl) -2-piperidine decarboxamide hydrochloride monohydrate.
PHYSIO – CHEMICAL PROFILE:
Molecular weight - 288
pKa - 8.1
Plasma protein binding - 95%
Partition coefficient - 28 (lipid solubility)
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T ½ - 210 min
Clearance - 8.3 l/min
MECHANISM OF ACTION:
Like all the other local anaesthetics, it inhibits Na channels. It decreases or prevents large transient increase in permeability of the cell membranes to Na ions that follows depolarization of the membrane and thereby blocks the nerve conduction. It also reduces the permeability of the resting nerve membrane to potassium ions as well as sodium ions and hence has got a stabilising action on all excitable membranes.
EFFECTS:
1) Local – nerve blockade
2) Regional – pain, temperature, touch, motor power and vasomotor tone supplied by the nerves are blocked.
3) Systemic – effects due to systemic absorption or accidental intravenous administration.
It is 4 times more potent than lignocaine but the onset of action is slower. The duration of action is longer. Sensory block is more marked than the motor block.
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SYSTEMIC EFFECTS:
Central Nervous System:
Can produce circumoral numbness, metallic taste, tinnitus, light headedness, dizziness, confusion, slurred speech, convulsions
Cardiovascular System:
Depresses automaticity and contractility of the heart and slows down the conduction of the cardiac action potential as there is prolongation of PR and QR intervals on ECG. Re-entrant phenomenon and ventricular arrhythmias may occur. All these results mostly from high lipid solubility. R-enantiomer is more toxic than S-enantiomer. Pregnancy increases cardiotoxic effects of bupivacaine KINETICS:
• Rapidly absorbed from the site of injection
• Peak systemic concentration – 5 to 30 minutes after administration
• Duration of action – 360 to 720 minutes
• Metabolism in liver – dealkylation to pipecoloxylidine, aromatic hydroxylation
• Excretion – 5% by kidney as unchanged drug and rest as metabolites
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PREPARATION:
• 0.25%, 0.5% solutions in 10, 20 ml vials, respectively
• 5mg/ml (0.5%) bupivacaine with 80 mg dextrose (to increase baricity) in 4 ml ampoules for subarachnoid injection (baricity – 1.0207)
USES:
• Central neuraxial blocks
• For local infiltration subcutaneously
• Peripheral nerve blockade
SIDE EFFECTS:
Bupivacaine exhibits selective cardiotoxicity. It is due to its lipophilicity and blockade of cardiac sodium channels. Accidental intravenous injection precipitates hypotension, cardiac dysrhythmias like sinus tachycardia, supraventricular tachycardia, atrioventricular heart block, ventricular tachycardia, premature ventricular contractions, wide QRS complexes and ST - T wave changes.
CONTRAINDICATIONS:
• Known hypersensitivity to amide local anaesthetics
• Intravenous regional anaesthesia (IVRA)
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MAXIMAL DOSE:
3 mg/kg body weight and the strength used is 0.25 – 0.75% with or without adrenaline (1:200000 or 1:400000). Adrenaline does not prolong its effect, but reduces its toxicity.
BUPIVACAINE VIAL
PHARMACOLOGY OF FENTANYL
Fentanyl is a phenylpiperidine derivative synthetic opioid agonist that is structurally related to meperidine. As an analgesic, fentanyl is 75 to 125 times more potent than morphine.
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CHEMICAL STRUCTURE
PHYSIOCHEMICAL PROFILE
Molecular weight - 286 pKa - 8.4 Plasma protein binding - 79-87%
Octanol water partition coefficient - 717 (highly lipid soluble) T ½ - 141-853 mins
Clearance - 13 ml/kg/min
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MECHANISM OF ACTION
Fentanyl citrate is a highly selective mu opioid receptor agonist which is specifically involved in the mediation of analgesia. It decreases the membrane excitability by inhibiting the pre- and post-synaptic responses. It interacts with the presynaptic Gi protein receptor leading to the hyperpolarisation of the cell membrane by increasing the potassium conductance. Inhibition of adenylate cyclase decreases the production of cyclic adenosine monophosphate and closure of voltage sensitive calcium channels.
SYSTEMIC EFFECTS CARDIOVASCULAR
Bradycardia is more prominent due to depression of carotid sinus baroreceptor reflex control of heart rate. It obtunds the cardiovascular responses to laryngoscopy and intubation. Allergic reactions are rare.
RESPIRATORY
Persistent or recurrent respiratory depression causes a decrease in tidal volume and respiratory rate. It diminishes the ventilatory response to hypoxia and hypercarbia. Chest wall rigidity (the wooden chest phenomenon) may occur due to the effect on mu receptors located on the GABA-ergic interneurons. It is a potent antitussive agent and bronchospasm is rare due to minimal histamine release.
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CENTRAL NERVOUS SYSTEM
It is a more potent analgesic than morphine with little hypnotic or sedative activity. Miosis occurs as a result of stimulation of Edinger Westphal nucleus. Myoclonus secondary to the depression of inhibitory neurons produces a clinical picture of seizure activity in the absence of EEG changes. In doses exceeding 30 micrograms/kg i.v produces changes in the somatosensory evoked potentials. It is associated with modest increase in the intracranial pressure when administered to head injury patients.
OTHERS
It decreases the gastrointestinal motility, decreases the gastric acid secretion and causes spasm of sphincter of Oddi. It increases the tone of ureters, bladder detrusor muscle and vesicular sphincter.
KINETICS
Administered intravenously, it has a more rapid onset and shorter duration of action due to greater lipid solubility and faster redistribution.75% of the initial dose undergoes first pass pulmonary uptake that limits the systemic distribution. Continuous i.v infusion saturates the inactive tissue sites like fat and skeletal muscles. Metabolized by N-demethylation to norfentanyl, hydroxypropionyl-fentanyl and hydroxypropionyl-norfentanyl. Longer elimination half time is because of larger volume of distribution and reuptake
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from inactive tissues. Substrate for cytochrome P450. 10% is excreted in urine unchanged and rest as metabolites.
PREPARATIONS
• 2 ml ampoule injections containing 50 micrograms per ml of fentanyl citrate.
• As transdermal patches delivering 75-100 micrograms / hour
• Oral transmucosal fentanyl lozenges mounted on a handle delivering 5-20 micrograms per kg.
• As fentanyl hydrochloride in an iontophoretic transdermal system.
USES
• Provides analgesic component in general anesthesia
• In combination with a major tranquilizer for neuroleptanalgesia
• Profound labour analgesia
• Agent for patient controlled analgesia
• In premedication and palliative care.
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TOXICITY / SIDE EFFECTS
• Post-operative respiratory depression due to secondary peak in plasma levels as fentanyl is absorbed from small intestine and eluted from muscles.
• Nausea, vomiting and dependence may complicate the use of this drug.
FENTANYL CITRATE AMPOULE
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REVIEW OF LITERATURE
Lew et al22 evaluated the effectiveness of epidural volume extension in 62 gravid females prepared for elective caesarean section ( n=31) by allocating them into two groups. The first group received combination of spinal and epidural anaesthesia with 5mg of 0.5% hyperbaric bupivacaine followed by 6 ml saline for epidural volume extension and the second group was provided with spinal anaesthesia with a dose of 9mg of 0.5% hyperbaric bupivacaine. He compared the sensory and motor block profile and also the hemodynamic status of the parturients. They proposed that patients in the EVE group showed a quicker motor recovery to modified Bromage scale 0 when matched with those who received spinal anaesthesia only. Hence they summarised that combined spinal epidural with EVE reduced the requirement of anaesthetic dose needed by as much as 55%. This study also justified the fact that CSE with epidural volume extension is associated with rapid motor recovery leading to a shorter recovery room stay and at the same time providing adequate anaesthesia for the surgery.
Salman et al23 conducted his study in three groups of full term pregnant females with 37-42 weeks of gestational age planned for elective caesarean section. Group 1 consisted of 48 females who were placed in the right lateral recumbent position and they were given spinal anaesthesia with 27G Quincke needle. Patients received single dose of 0.5% levobupivacaine with 20
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micrograms of fentanyl and the dosage was determined according to their heights.
• Patients with height < 160 cm were given 10 mg of the drug
• Patients with height 161 - 164 cm were given 12 mg of the drug
• Patients with height 165 - 169 cm were given 14mg of the drug
• Patients with height > or equal to 170 cm were given 15mg of levobupivacaine.
In the second group, 5ml of saline was given as epidural volume extension in addition to the spinal dosage of drug as described above. Group 3 patients were anaesthetised with CSE with 5 ml of 0.5% levobupivacaine as epidural volume extension respectively. From this study, it was drawn that adequate and rapid motor and sensory block with a faster onset, higher sensory level and longer duration was produced in group 2 and 3 and these effects were more significant in the third group.
Kaur and Jayant et al24 randomised 105 females between the age group of 25 and 40 years of ASA physical status 1 and 2 planned for caesarean section into 3 groups of 35 each. Group B7 were anaesthetised with 7 mg of 0.5%
hyperbaric bupivacaine. Group B7- EVE were given 7mg of 0.5% hyperbaric bupivacaine proceeded by 10 ml of saline in the epidural catheter 5 minutes later and Group B10 were spinal anaesthetised with 10 mg of 0.5% hyperbaric
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bupivacaine without epidural volume extension. All the three groups also received 25 micrograms of intrathecal fentanyl as an additive. This lead to a conclusion that sufficient anaesthesia with quick motor recovery could result from epidural volume extension when spinal and epidural anaesthesia are combined.
Vanhelder T et al25 studied the role of combined spinal epidural anaesthesia in managing parturients with valvular heart defects. They have presented a case of successful anaesthetic management of a parturient with moderate mitral stenosis and aortic insufficiency. They concluded that prudently planned regional anaesthetic technique (CSEA) was safely used for both labour and caesarean section in parturients with valvular heart diseases.
Asha Tyagi and colleagues26 conducted a prospective sequential allocation study in adult males between the age group of 18 and 60 years belonging to physical status 1 and 2 scheduled for lower limb surgeries under combined spinal epidural anaesthesia to determine the maximum effective volume of normal saline for epidural volume extension. An inadequate level was defined as lower than T10 at 10 mins after the intrathecal injection with 10 mg of hyperbaric bupivacaine with no ascent for two consecutive readings taken 2 mins apart. The EVE was performed with normal saline injected through epidural catheter and was considered successful if the level of sensory block increased by two or more dermatomal segments within 5 mins of the injection.
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The volume of normal saline for EVE was decided by using up and down method with the first patient receiving 10 ml and a dosing interval of 1 ml in subsequent patients. The minimum effective volume with 95% confidence interval was calculated using Dixon and Massey’s formula. They concluded that the minimum effective volume of normal saline to raise the level of sensory block by two or more dermatomal segments within 5 mins of EVE is 7.4 ml (95% confidence interval 5.5 – 9.9 ml).
Gokce et al27 enumerated the importance of the volume effect and migration of the spinal anaesthetic drug produced by the epidural injection of 10 ml of normal saline soon after the administration of intrathecal bupivacaine. He emphasised that there is an increase in the cephalad extent of the sensory block.
Takiguchi et al28 carried out a myelographic study where he observed the
“thecal compression” proceeding epidural volume extension. He selected a group of healthy adult volunteers for whom contrast medium was administered intrathecally and he positioned them 45 degrees upright. When 5 ml aliquots of normal saline was injected subsequently into the epidural space, they visualised the ascent of the contrast medium level in the subarachnoid space. They also showed 40% deduction in the diameter of subarachnoid space following the first aliquot of normal saline and 25% deduction soon after the second aliquot. With the third and fourth aliquots, the diameter of subarachnoid space decreased further; but the maximum reduction occurred after the first epidural injection.
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They came to a proposal that the degree of thecal compression is directly proportional to the volume injected into epidural space, with larger epidural volumes producing greater compression.
Loubert and colleagues29 chose 90 pregnant patients undergoing elective caesarean section randomly and segregated them into three groups of 30 each.
Group B 7.5 were given 7.5 mg of 0.5% hyperbaric bupivacaine spinally. Group B 7.5-EVE were spinally anaesthetised with 7.5 mg of 0.5% hyperbaric bupivacaine followed by EVE with 5 ml of normal saline and 10 mg of 0.5%
hyperbaric bupivacaine was given to group B 10. They embarked that median motor scores and Bromage scores were higher in group B10 and B7.5 comparing B 7.5 – EVE. They also highlighted that 5 ml of normal saline for EVE could not produce ample sensory anaesthesia and this volume was insufficient to overcome gravity.
Hideyuki Higuchi et al30 experimented the sequalae of epidural saline injection on the cerebrospinal fluid volume and velocity waveform by magnetic resonance imaging study. He allocated three groups of patients randomly and injected saline into the epidural space via the catheter. First group of patients received 5 ml saline epidurally, 10 ml saline was administered to the second group, and the third group was given 15 ml of saline. Comparison of cerebrospinal fluid volume and velocity waveform before and after epidural injection was visualised by serial repeated images. Seven axial images at disc
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levels from T11 – T12 to L5 – S1 were taken before injection and 1, 3, 5, 10, 15, 20, 25, 30 mins after saline injection. The dural area before and after saline injection was compared and contrasted. They summarised the mean reduction in the CSF volumes and it is as follows
• 2.0 +/- 1.0 ml reduction in the five ml group
• 4.4 +/- 1.4 ml reduction in the ten ml group
• 7.2 +/- 2.6 ml reduction in the fifteen ml group
After the epidural injection of saline, they drew a conclusion that the CSF velocity waveform did not synchronise with the cardiac cycle and it was crystal clear among the patients of 10 ml group. This proved the dependency of the injected saline volume on the reduction in CSF volume. There was no relationship between the CSF flow dynamics and dural sac compression which lasted for a minimum period of 30 mins during the study.
Akhilesh Kumar Tiwari et al31 highlighted the efficiency of epidural volume extension technique in CSEA in patient of different specialities with compromised cardiac functional status. Study included patients with global hypokinesia with left ventricular dysfunction ( EF < 30% ), trauma patients with systemic illness like diabetes mellitus, coronary artery disease , ischemic cardiomyopathy, severe right ventricular dysfunction and severe pulmonary artery hypertension planned for knee amputation, primigravida at 36 weeks
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gestation presenting with peripartum cardiomyopathy planned for elective caesarean section, and 23 yrs old primigravida diagnosed with Takayasu arteritis along with bilateral subclavian and renal artery involvement with dilated cardiomyopathy. All these patients underwent successful surgery by using EVE’s technique using 1ml of 0.5% ropivacaine and 25 micrograms of fentanyl followed by 8 ml of normal saline through epidural catheter 5 mins after subarachnoid block. The novelty of this technique was recognized by the stable hemodynamic parameters and achievement of desired blockade.
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AIM OF THE STUDY
To evaluate the effectiveness of epidural volume extension using 10 ml of 0.9 % saline in combined spinal epidural anaesthesia to perform adequate neuroaxial blockade using low dose of intrathecal hyperbaric bupivacaine in lower limb orthopaedic surgeries.
PRIMARY OBJECTIVES
• Level of maximum sensory blockade
• Time to reach maximum sensory blockade
• Two segment regression time of sensory blockade
• Time to reach maximum motor blockade
• Time to recover from motor blockade
SECONDARY OBJECTIVE
• Time at which the first rescue analgesia is given epidurally
• Blood pressure and heart rate variations are observed
• Top up doses of bupivacaine required
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MATERIALS AND METHODS PATIENT SELECTION
After getting approval from the Institutional Ethics Committee of Govt.
Kilpauk Medical College and written informed consent from patients / relatives, 80 patients of ASA 1 and 2 who underwent elective lower limb orthopaedic surgeries in supine position at Govt. Kilpauk Medical College Hospital and Govt. Royapettah Hospital were enrolled in this study group.
INCLUSION CRITERIA
• Age above 40 years and below 70 years
• Height > 150 cm and < 170 cm
• Weight 40 – 75 kg
• Males and females.
• ASA physical status 1 and 2.
• Patients undergoing elective lower limb orthopedic surgeries in supine position
• Who have given valid informed consent
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EXCLUSION CRITERIA
• ASA physical status 3 and 4
• Patients who refuse regional anaesthesia.
• Patients with an increase in intracranial pressure
• Intrinsic or idiopathic coagulopathy
• Skin or soft tissue infection at the proposed site of needle insertion
• Severe hypovolemia
• Pre-existing neurological disease like lower extremity peripheral neuropathy.
• Emergency orthopedic surgeries
• Orthopaedic surgeries not done in supine posture.
• Surgeries lasting for more than 3 hrs.
• Patients with known allergy to study drugs
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MATERIALS
• Boyles machine with circle CO2 absorber circuit.
• 16 G or 18 G Tuohy epidural needle with 18 G or 20 G epidural catheter and LOR syringe
• 25 G or 23 G Quincke’s Spinal needle
• Local anaesthetic 0.5% hyperbaric bupivacaine, Injection 2%
lignocaine with adrenaline (1 in 200000)
• Loaded 5 ml syringe containing 30 mg of ephedrine and 2 ml syringe containing 1.2 mg of atropine.
• Mcintosh laryngoscope with blades 3 and 4
• Endotracheal tubes 7, 7.5 and 8 mm CETT
• Emergency drugs, intravenous fluids and other resuscitative equipments.
• Preloaded 10 ml syringe with normal saline.
GROUPS
Group A: Combined spinal epidural anaesthesia with epidural volume extension of saline (CSE-EVE).
Group B: Combined spinal epidural anaesthesia alone (CSE).
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METHODOLOGY
This study was designed as a prospective randomised control study.
Patients were preoperatively evaluated, clinically examined and proper investigations were done prior to assessment. Procedure was explained in detail and written consent was obtained. After ascertaining the inclusion criteria, preoperative investigations were recorded.
ANAESTHESIA PROCEDURE
After preparation of all requirements of both regional and general anaesthesia, CSE was performed under strict aseptic precautions with patient in sitting position at L2 – L3 or L3 - L4 interspace using low dose intrathecal hyperbaric bupivacaine 10 mg ( 2 ml of 0.5% bupivacaine ) and 25 micrograms ( 0.5 ml ) of fentanyl. Epidural was first performed using 16 G or 18 G Tuohy needle by loss of resistance to air technique and 18 G or 20 G epidural catheter was inserted in a cephalad direction 4 - 6 cm into epidural space and secured.
Spinal anaesthesia was then performed using 25 G or 23 G Quincke’s needle in a different interspace. Five minutes after performing the block, 10 ml of sterile preservative free 0.9 % normal saline was injected in the epidural space.
In the second group patients were anaesthetized using combined spinal epidural without epidural volume extension using the same technique and the same dose of intrathecal hyperbaric bupivacaine and fentanyl. An effective dose is defined as one that resulted in a sensory block height of T 10 level within 20
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minutes of intrathecal injection with no epidural top up. Any episodes of hypotension (systolic blood pressure < 20% from baseline) was treated by administering titrated intravenous bolus of ephedrine 6 mg and intravenous fluids. Bradycardia (Heart rate < 25% from baseline) was treated with intravenous bolus of atropine 0.6 mg. When an ineffective blockade occurred during the study, surgery was carried out subsequently with epidural top up or converted to general anaesthesia. Post operatively patients were observed for any complications like postdural puncture headache, urinary retention and infections for 48 hours. The epidural catheter was removed thereafter.
Anaesthesia monitoring and parameters analysed:
Pulse rate, noninvasive blood pressure, pulse oximetry (SPO2), ECG, were recorded throughout the surgery. The level of maximum sensory blockade, time to reach maximum sensory blockade (min) and two segment regression time was determined by pinprick test. The time to reach maximum motor blockade (Bromage 3) and the time to recover from motor blockade (min) was also recorded. Motor blockade was assessed by Modified Bromage Scale.
Scale 0 - able to move the hip, knee and ankle
Scale 1 – unable to move the hip, able to move the knee and ankle Scale 2 – unable to move the hip and knee, able to move the ankle Scale 3 – unable to move the hip, knee and ankle
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The blood pressure and heart rate changes were observed at various intervals (at the 5th, 10th, 15th, 20th min and then every fifteen minutes thereafter at the 35th, 50th, 65th and 80th min) of surgery. The top up doses of bupivacaine given through the epidural catheter in case of ineffective spinal anaesthesia and the requirement of ephedrine and atropine were also recorded which was the secondary outcome of the study.
Data Analysis
Descriptive statistics was done for all data and were reported in terms of mean values and percentages. Suitable statistical tests of comparison were done.
Continuous variables were analysed with the unpaired t test.. Categorical variables were analysed with the Chi-Square Test and Fisher Exact Test.
Statistical significance was taken as P < 0.05. The data was analysed using SPSS version 16 and Microsoft Excel 2007. Assuming that 80 percent as power of the study, minimum sample size required for the study was calculated to be 70.In our study 80 subjects were chosen.
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Groups
Group Intervention Number
Group CSE - EVE Combined spinal epidural with epidural volume extension
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Group CSE Combined spinal epidural 40
Null Hypothesis
Null Hypothesis : H0
Combined spinal epidural with epidural volume extension with normal saline is equal in effect to Combined spinal epidural in patients undergoing lower limb orthopedic surgeries using low dose of intrathecal hyperbaric bupivacaine
Alternate Hypothesis : H1
Combined spinal epidural with epidural volume extension with normal saline is superior in effect to Combined spinal epidural in patients undergoing lower limb orthopedic surgeries using low dose of intrathecal hyperbaric bupivacaine
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OBSERVATION AND RESULTS
• A total of 80 patients of ASA- PS1 and PS2 were studied.
• Forty patients were enrolled into each of the two groups (A and B).
• There was no statistical significance between the two groups when the demographic parameters like age distribution, sex distribution, weight and height of the patients were compared.
• The comparison of parameters like, level of sensory block attained, two segment regression time, time for maximum sensory blockade to be achieved, time to achieve maximum motor blockade and the requirement of top up doses of bupivacaine was found to be statistically significant between the two groups.
• Blood pressure and heart rate changes were insignificant between the two groups.
• All the 80 patients underwent elective lower limb orthopaedic procedures done in supine position only.
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Age
Age Distribution Group CSE –
EVE % Group CSE %
≤ 40 Years 1 2.50 0 0.00
41-50 Years 17 42.50 18 45.00
51-60 Years 14 35.00 14 35.00
61-70 Years 8 20.00 8 20.00
Total 40 100 40 100
Age Distribution Group CSE - EVE Group CSE
N 40 40
Mean 53.13 53.15
SD 8.09 7.24
P value
Unpaired t Test 0.9884
1
17
14
8
0
18
14
8
0 5 10 15 20
≤ 40 Years 41-50 Years 51-60 Years 61-70 Years
Number of Patients
Age Distribution
Group CSE - EVE Group CSE
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Among the patients undergoing lower limb orthopedic surgeries using low dose of intrathecal hyperbaric bupivacaine, there was no statistically significant difference in relation to age distribution between group CSE - EVE (mean=53.13, SD=8.09) and group CSE (mean=53.15, SD=7.24) with a p value of >0.05 as per unpaired t test. Therefore we fail to reject the null hypothesis that there is no difference in age distribution between the intervention groups.
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Gender
Gender Status Group CSE -
EVE % Group CSE %
Male 28 70.00 31 77.50
Female 12 30.00 9 22.50
Total 40 100 40 100
P value
Chi Squared Test 0.4459
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12 31
9
0 5 10 15 20 25 30 35
Male Female
Number of Patients
Gender Status
Group CSE - EVE Group CSE
